Reasons for adding or updating:

• Change to section 4.2 - Posology and method of administration
• Change to section 4.8 - Undesirable effects
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 6.5 - Nature and contents of container
• Correction of spelling/typing errors

Date of revision of text on the SPC: 08-Jul-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

•        Section 4.2 – Posology: revised the recommended dosage for Rheumatoid Arthritis (RA) and Ankylosing spondylitis (AS) from 90mg to 60mg once daily

•        Section 4.8 – Undesirable effects: updated number of patients in summary of safety profile.

•        Section 5.1 – Pharmacodynamic properties: updated clinical efficacy details concerning RA and AS

•        Section 6.5 – Nature and contents of container: Added the 98 tablets mono-pack size for Arcoxia 30mg and 60mg and corrected the spelling of ‘aluminium’

•        Minor editorial and formatting changes in section 4.3, 4.5, 5.1, 5.2 and 5.3

Reasons for adding or updating:

• Change to section 7 - Marketing authorisation holder
• Change to section 8 - Marketing authorisation number(s)
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 31-Oct-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 7 – Marketing authorisation holder:  The address of the Marketing authorisation holder has been changed from 'MSD UK' to ‘Merck Sharp & Dohme B.V., Waarderweg 39, Haarlem, 2031 BN, The Netherlands’

Section 8 – Marketing authorisation number: The MA numbers have  been updated to PL 04900/0001-0004

Section 10 – Date of revision: 31 October 2015 has been added as the Date of revision

Reasons for adding or updating:

• Change to section 2 - Qualitative and quantitative composition
• Change to section 3 - Pharmaceutical form
• Change to section 4.1 - Therapeutic indications
• Change to section 4.2 - Posology and method of administration
• Change to section 4.3 - Contraindications
• Change to section 4.8 - Undesirable effects - how to report a side effect
• Change to section 5.1 - Pharmacodynamic properties
• Change to section 5.2 - Pharmacokinetic properties
• Change to section 6.6 - Special precautions for disposal and other handling
• Change to section 9 - Date of first authorisation/renewal of the authorisation
• Change to section 10 - Date of revision of the text

Date of revision of text on the SPC: 14-Mar-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

• Section 2 – Qualitative and quantitative composition: Wording updated in the reference to excipients in line with the QRD template.

• Section 3 – Pharmaceutical form: Section updated in line with the latest QRD template
• Section 4.1 – Therapeutic indication: This section of the SmPC was updated to define the target population indicated for the use of this drug.
• Section 4.2 – Posology and method of administration: Subheading and headings updated in line with the QRD template; also wording added to the paragraph under the subheading ‘Postoperative dental surgery pain’ regarding the treatment period for Arcoxia.
• Section 4.3 – Contra-indications: The third bullet point has been updated as follows:

·         Patients who, after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticarial, or allergic-type reactions. after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors

• Section 4.8 – Undesirable effects: The heading ‘Adverse Experience Term’ in table 1 has been replaced with ‘Adverse Reactions’, in accordance with the QRD template. Addition of AE reporting statement for the UK.
• Section 5.1 – Pharmacodynamic properties: Section updated in line with the latest QRD template
• Section 5.2 – Pharmacokinetic properties: Subheadings revised as per the QRD template.
• Section 6.6 – Special precautions for disposal: Addition of statement on disposal of unused medicinal product in line with the QRD template.
• Section 9 – Date of Authorisation/renewal of authorisation: Section updated in line with the latest QRD template

Reasons for adding or updating:

• New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Legal Category:POM

Black Triangle (CHM): NO